Actively Recruiting
A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
Led by Takeda · Updated on 2026-05-08
110
Participants Needed
40
Research Sites
372 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main aim of this study is to see how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study will be done in 2 parts: Part A will include both children and teenagers, while part B will only include children. At first, only teenagers who meet the study rules can participate in this study. Children may only start to participate once enough information has been collected from other studies with zasocitinib. Participants in Part A will initially be assigned to receive either zasocitinib or placebo for the first 16 weeks of treatment, then all participants will receive zasocitinib through the end of the study. All participants in Part B will be assigned to receive treatment with zasocitinib throughout the study. Participants will be in the study for up to 4 years and 2 months (217 weeks), including up to 35 days for the screening period, 208 weeks of treatment (Part A and Part B) and a 4-week safety follow-up period. During the study, participants will visit their study site multiple times.
CONDITIONS
Official Title
A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic plaque psoriasis for at least 6 months before screening
- Stable plaque psoriasis with no significant flare or change in psoriasis for at least 6 months before screening
- Moderate-to-severe plaque psoriasis with a PASI score of 12 or greater and a sPGA score of 3 or greater at screening and Day 1
- Plaque psoriasis covering 10% or more of total body surface area at screening and Day 1
- Candidate for phototherapy or systemic therapy
- For Part A Cohort 1: male or female aged 12 to less than 18 years
- For Part A Cohort 2 and Part B: male or female aged 4 to less than 12 years
- For Part A Cohort 1: weight of 40 kilograms or more at screening
You will not qualify if you...
- Presence of nonplaque psoriasis types such as erythrodermic, pustular, predominantly guttate, predominantly inverse, or drug-induced psoriasis (limited inverse psoriasis allowed)
- Need for systemic treatment other than NSAIDs for an immune-related disease during the trial
- Skin conditions that could interfere with study assessments
- History or signs of active or latent tuberculosis infection
- Active herpes virus infections or history of serious herpetic infection
- History of chronic or recurrent bacterial infections
- History of opportunistic infections like Pneumocystis jirovecii pneumonia
- Any serious medical condition or abnormal clinical findings posing undue risk or affecting study results
- Prior use of zasocitinib or other TYK2 inhibitors unless confirmed not to have received TYK2 inhibitor
- Not up to date on required vaccinations according to pediatric immunization guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Exalt Clinical Research
Chula Vista, California, United States, 91910
Actively Recruiting
2
First OC Dermatology Research Inc.
Fountain Valley, California, United States, 92708
Actively Recruiting
3
Direct Helpers Medical Center
Hialeah, Florida, United States, 33012
Actively Recruiting
4
Arlington Dermatology
Rolling Meadows, Illinois, United States, 60008-3811
Actively Recruiting
5
Apex Clinical Research Center, LLC
Canton, Ohio, United States, 44718
Actively Recruiting
6
Wright State Physicians
Fairborn, Ohio, United States, 45324
Actively Recruiting
7
Apex Clinical Research Center, LLC
Mayfield Heights, Ohio, United States, 44124-4005
Actively Recruiting
8
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
9
UT Physicians Dermatology - Bellaire Station
Bellaire, Texas, United States, 77401
Not Yet Recruiting
10
Texas Dermatology and Laser Specialists-San Antonio
San Antonio, Texas, United States, 78218-3128
Actively Recruiting
11
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
12
Beijing Children Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
13
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510091
Not Yet Recruiting
14
Hunan Children's Hospital
Changsha, Hunan, China, 410007
Actively Recruiting
15
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
16
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
17
Huashan Hospital Fudan University
Shanghai, China, 200040
Actively Recruiting
18
Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, Hesse, Germany, 60596
Not Yet Recruiting
19
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, Germany, 48455
Actively Recruiting
20
Uniklinik Koln, Klinik fur Dermatologie und Venerologie
Cologne, North Rhine-Westphalia, Germany, 50937
Not Yet Recruiting
21
University Hospital of Muenster
Münster, North Rhine-Westphalia, Germany, 48145
Not Yet Recruiting
22
Universitätsklinikum Bonn
Bonn, Germany, 53127
Not Yet Recruiting
23
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, Germany, 55131
Not Yet Recruiting
24
Presidio Ospedaliero Gaspare Rodolico
Catania, Sicily, Italy, 95123
Not Yet Recruiting
25
Universita Degli Studi Di Padova
Padova, Italy, 35121
Not Yet Recruiting
26
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Not Yet Recruiting
27
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
28
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, Fukuoka, Japan, 807-8555
Actively Recruiting
29
Mie University Hospital
Tsu, Mie, Mie-ken, Japan, 514-8507
Actively Recruiting
30
Nippon Life Hospital
Osaka, Osaka, Japan, 550-0006
Actively Recruiting
31
Teikyo University Hospital
Itabashi-Ku, Tokyo, Japan, 173-0003
Actively Recruiting
32
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
Not Yet Recruiting
33
Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
Lublin, Lublin Voivodeship, Poland, 20-573
Not Yet Recruiting
34
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
Not Yet Recruiting
35
Centrum Badan Klinicznych Pi-house Sp. Z O. O.
Gdansk, Pomeranian Voivodeship, Poland, 80-546
Not Yet Recruiting
36
"DERMED" Centrum Medyczne Sp. z o. o.
Lodz, Poland, 90-265
Not Yet Recruiting
37
Dermoklinika-Centrum Medyczne s.c
Lodz, Poland, 90-436
Not Yet Recruiting
38
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain, 15706
Not Yet Recruiting
39
Hospital de La Santa Creu i Sant Pau - Dermatologia
Barcelona, Spain, 08041
Not Yet Recruiting
40
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Not Yet Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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